Clients are made aware that The Food and Drug Administration (FDA or Agency) is issuing a regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.

Note: This rule is effective July 22, 2013.

A Glimpse of the Highlights of this Regulation by FDA:

       1: What is the scope of this subpart?

This subpart applies to combination products. It establishes which current good manufacturing practice requirements apply to these products. This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.

  2: What current good manufacturing practice requirements apply to your combination product?

If you manufacture a combination product, the requirements listed in this section apply as follows:

• The current good manufacturing practice requirements in parts 210 and 211 of this chapter apply to a combination product that includes a drug constituent part;
• The current good manufacturing practice requirements in part 820 of this chapter apply to a combination product that includes a device constituent part;
• The current good manufacturing practice requirements among the requirements (including standards) for biological products in parts 600 through 680 of this chapter apply to a combination product that includes a biological product constituent part to which those requirements would apply if that constituent part were not part of a combination product; and
• The current good tissue practice requirements including donor eligibility requirements for HCT/Ps in part 1271 of this chapter apply to a combination product that includes an HCT/P.

Other parts that have been thrown a light on include requirements to comply with this new rule, various comments and respective responses on them in regards to this final rule, various definitions covered by FDA etc.

If you need to review this regulation in detail you can log on to: Current Good Manufacturing Practice Requirements for Combination Products

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IEmail us at [email protected] to discuss more about this new regulation on cGMP for combination products and Ref: cGMP requirements for Combination Products